Subgingival Clamp Versus Retraction Cord in Cervical Lesions in Term of Technique Sensitivity and Gingival Health
Primary Purpose
Gingival Retraction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
retraction cord
subgingival clamp
Sponsored by
About this trial
This is an interventional other trial for Gingival Retraction
Eligibility Criteria
Inclusion Criteria:
- Subject not less than 18 years of age.
- Males or females.
- Have at least one carious or non-carious cervical lesion.
- Cervical lesions should be equi-gingival or subgingival.
- Can comply to oral hygiene measures or with good oral hygiene.
- Have sufficient cognitive ability to understand consent procedures.
- Vital upper or lower teeth with no signs or symptoms of irreversible pulpitis.
- Clinically healthy gingiva and periodontium.
- No evidence of attachment loss, bleeding on probing, or plaque accumulation.
Exclusion criteria:
- Exclusion Criteria:
- Patients less than 18 years old.
- Disabilities (mental health conditions, intellectual disability and physical disabilities).
- Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, -hypertensive, epileptic.
- Lack of compliance.
- Gingival hyperplasia, blood disorder.
- Attachment loss signs of periodontal disease.
- Patients contra-indicated for rubber dam placement (Asthmatic patient, mouth breather, -- partially erupted tooth, extremely malposed teeth and latex allergy).
- Periapical pathosis or signs of pulpal posterior or anterior pathology.
- Non-vital tooth.
- Endodontically treated tooth.
- Sever periodontal affection.
- Tooth indicated for extraction.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
retraction cord
subgingival clamp
Arm Description
Outcomes
Primary Outcome Measures
Time of application
Assessed using timer and the measuring unite is seconds
Number of patients need local anesthesia
It will be measured by patient self assessment for the need of local anesthesia through a Yes/No question
Degree of isolation from cervical fluids
Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result
Degree of patient satisfaction
Using visual analogue scale (units on scale from 0-10)
Secondary Outcome Measures
Pink esthetics evaluation
Using a pink esthetic score with a grades from 0-2
Amount of gingival bleeding
Assessed using a score for gingival hemorrhage from 0 -2
Presence of gingival laceration
Occurence of gingival laceration assessed visually using magnifying loup with a Yes/No result
Degree of gingival sensitivity
Assessed using visual analogue scale (units on scale from 0-10)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03917108
Brief Title
Subgingival Clamp Versus Retraction Cord in Cervical Lesions in Term of Technique Sensitivity and Gingival Health
Official Title
Assessment of Technique Sensitivity and Gingival Health in Management of Cervical Lesions Performed Using Subgingival Clamp Versus Retraction Cord: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
assessing subgingival clamp in handling and retracting the gingival tissue at the cervical area to see its effect on the gingival health and its technique sensitivity compared to the most commonly used method (retraction cord), as gingival displacement for cervical restorations affects smile and therefore patient satisfaction with the result.
Detailed Description
Gingival displacement for restoring cervical lesions using retraction cord or subgingival clamp with their technique sensitivity affects the smile as they may cause gingival bleeding, laceration or recession and therefore affects patient satisfaction. There are several methods to achieve retraction; retraction cord is the most commonly used method. It controls the soft tissue displacement, gingival bleeding and expose the margins which provide good visualization and access.
They are effective and safe if the gingiva is healthy, also inexpensive retraction method. However, the use of retraction cord has some disadvantages like: it is time consuming, may cause gingival recession after healing and bleeding after removal, its application needs practice and skill as improper handling of the cord can cause traumatic injuries, gingival recession and marginal exposure of the restoration, it may cause postoperative discomfort and pain for the patient and finally leaving the retraction cord for long time or forgetting to remove it from the sulcus can cause permanent damage to the gingival tissue.
Using gingival retracting clamps with rubber dam isolation prevent the gap caused around the teeth due to vertical and horizontal tissue displacement occurred beneath the area of dento-gingival attachment upon the application of the retraction cord. Also, after clamp stabilization in position, it prevents accidental slippage and trauma to surrounding soft tissue during the restorative procedure. They also provide maximum tissue retraction without laceration of gingival tissues. Also, their availability in different sizes and shapes provide a good adaptation to any tooth configuration and any inaccessible area.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Retraction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
retraction cord
Arm Type
Active Comparator
Arm Title
subgingival clamp
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
retraction cord
Intervention Description
retraction cord ( Ultra dent sizes #0, #00, #000 ) is placed in the gingival sulcus using blunt instrument and using cotton roll isolation.
Intervention Type
Device
Intervention Name(s)
subgingival clamp
Intervention Description
subgingival clamp (KSK clamps W8A, #44, #42, #43) or (Brinker clamps B5, B6) is placed to retract the gingiva with rubber dam isolation
Primary Outcome Measure Information:
Title
Time of application
Description
Assessed using timer and the measuring unite is seconds
Time Frame
Immediately after application
Title
Number of patients need local anesthesia
Description
It will be measured by patient self assessment for the need of local anesthesia through a Yes/No question
Time Frame
Immediately after application
Title
Degree of isolation from cervical fluids
Description
Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result
Time Frame
Immediately after application
Title
Degree of patient satisfaction
Description
Using visual analogue scale (units on scale from 0-10)
Time Frame
Immediately after application
Secondary Outcome Measure Information:
Title
Pink esthetics evaluation
Description
Using a pink esthetic score with a grades from 0-2
Time Frame
4 month
Title
Amount of gingival bleeding
Description
Assessed using a score for gingival hemorrhage from 0 -2
Time Frame
4 month
Title
Presence of gingival laceration
Description
Occurence of gingival laceration assessed visually using magnifying loup with a Yes/No result
Time Frame
4 month
Title
Degree of gingival sensitivity
Description
Assessed using visual analogue scale (units on scale from 0-10)
Time Frame
4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject not less than 18 years of age.
Males or females.
Have at least one carious or non-carious cervical lesion.
Cervical lesions should be equi-gingival or subgingival.
Can comply to oral hygiene measures or with good oral hygiene.
Have sufficient cognitive ability to understand consent procedures.
Vital upper or lower teeth with no signs or symptoms of irreversible pulpitis.
Clinically healthy gingiva and periodontium.
No evidence of attachment loss, bleeding on probing, or plaque accumulation.
Exclusion criteria:
Exclusion Criteria:
Patients less than 18 years old.
Disabilities (mental health conditions, intellectual disability and physical disabilities).
Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, -hypertensive, epileptic.
Lack of compliance.
Gingival hyperplasia, blood disorder.
Attachment loss signs of periodontal disease.
Patients contra-indicated for rubber dam placement (Asthmatic patient, mouth breather, -- partially erupted tooth, extremely malposed teeth and latex allergy).
Periapical pathosis or signs of pulpal posterior or anterior pathology.
Non-vital tooth.
Endodontically treated tooth.
Sever periodontal affection.
Tooth indicated for extraction.
12. IPD Sharing Statement
Learn more about this trial
Subgingival Clamp Versus Retraction Cord in Cervical Lesions in Term of Technique Sensitivity and Gingival Health
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